Infusion filter and method for performing thrombolysis

ABSTRACT

An infusion filter design combines a fluid infusion device and a blood filtration device that filter blood during a thrombolysis procedure while allowing for complete filter removal on procedure completion. In one embodiment, a wire comprises a proximal, non-infusible length that extends partially outside of the patient and within the vein. The wire further comprises an infusible length distally from the non-infusible length that is extends within the vein so as to be placed at the section of the vein requiring medication. The wire also comprises a distal filter component at a distal end of the wire that is employed to filter the blood in the event that during the period that clot is dissolved it migrates toward the central circulation.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/310,456 which was filed on Mar. 18, 2016 titled INFUSION FILTERDESIGN and is a continuation in part of U.S. patent application Ser. No.14/819,258 filed on Aug. 5, 2015 titled INTRAVENOUS FILTER WITHGUIDEWIRE AND CATHETER ACCESS GUIDE, which application is a continuationin part of U.S. patent application Ser. No. 12/012,136 filed on Jan. 30,2008 titled IMPROVED INTRAVENOUS DEEP VEIN THROMBOSIS FILTER AND METHODOF FILTER PLACEMENT, which claims priority to U.S. Provisional PatentApplication No. 60/898,939 filed on Jan. 31, 2007 titled IMPROVEDINTRAVENOUS DEEP VEIN THROMBOSIS FILTER AND METHOD OF FILTER PLACEMENT.

BACKGROUND

1. Field

The disclosed embodiments relate to vascular filters and, in particularto surgically implanted vascular filters which capture blood clots toprevent the clots from migrating to other regions of the circulatorysystem.

2. Related Art

Deep vein thrombosis (DVT) is a common problem and causes significantmorbidity and mortality in the United States and throughout the world.DVT is the formation of a blood clot within a deep vein, predominantlyin the legs. These blood clots typically occur due to slow or reducedblood flow through the deep veins such as when the patient cannotambulate or otherwise efficiently circulate their blood. Another causeof inefficient circulation may be due to structural damage to the veinsresulting from general trauma or surgical procedures. Additionally, ablood clot may form in a deep vein due to a particular medical conditionor a propensity for the patient to have a hypercoaguability state. Forexample, a woman on birth control who smokes has an increased risk offorming blood clots and is thus predisposed to DVT.

The result and clinical significance of DVT is when the clot breaks freefrom its location in the deep vein of the leg. The clot travels throughthe circulatory system and may eventually lodge in a location that isadverse to the patient's health. For example, the clot may dislodge froma location in the deep vein of the patient's leg and migrate through theheart and come to rest in the patient's lung causing a pulmonaryembolism (PE) resulting in the restricted circulation of blood in thelungs. PE may cause sudden death for the patient. As many as 600,000cases of clinically significant Pulmonary Embolus occur and result inapproximately 200,000 deaths annually in the United States.

DVT & PE are currently prevented in several ways includinganticoagulation therapy, thrombectomy, thrombolysis and inferior venacava filter (IVC filter) placement. Anticoagulation therapy utilizesvarious medications that reduce the patient's propensity for formingblood clots. However, this form of therapy has the disadvantage that dueto the patient's inability to form blood clots (due to the medication),there is an increased risk of excessive bleeding should the patientbecome injured, sustain surgical complications, or develop internalhemorrhaging.

Thrombectomy is a procedure generally performed for treatment of a PE,in which a blood clot is extracted from the vein using a surgicalprocedure or by way of an intravenous catheter and a mechanical suctiondevice. This form of treatment is risky and technically very difficultbecause the catheter has to be steered or navigated to a specificlocation in order to extract the clot. Additionally, during athrombectomy there is an increased risk of causing vascular damage dueto the surgical procedure and use of various mechanical devices.

Thrombolysis is a medical technique that is performed for treatment of aPE, in which various medicines are infused into the region of the clotthat subsequently causes the clot to dissolve. This form of treatmenthas the disadvantage that the medication may cause bleeding at othersites such as within the brain. For example, if a patient has previouslyhad a minute non-clinical stroke, the medication used in a thrombolysismay cause a previously healed vessel to bleed within the patient's head.

IVC filter placement is usually conducted by surgically installing afilter in a large bore vein (such as the inferior vena cava) in thepatient's upper abdomen. The IVC filter is placed using a large borecatheter (Introducer Catheter) introduced into the patient from thepatient's jugular vein and steered to the inferior vena cava fordelivery of the filter. Typically, a removable IVC filter is utilizedbased on FDA recommendations to remove the IVC filter once protectionfrom PE is no longer needed. In the case where a removable filter isutilized, additional complications arise when the filter must beremoved.

The removable IVC filter is generally placed for a time period of aseveral weeks to a few months to prevent internal vascular scaring.However, removal of the IVC filter is technically challenging andrequires large bore access. In practice, the removable IVC filter iscaptured by first accessing a large bore vein, such as the jugular vein,using a large bore catheter to approach the filter, capturing the tip ofthe filter using a “snaring device” that is deployed through the largebore catheter, then pulling the filter into the catheter, and then thelarge bore catheter (with the filter therein) is removed from thepatient. This procedure is very challenging, and requires increasedpatient recovery time.

Current IVC filter placement has several disadvantages such as increasedcosts, requires the use of special surgical procedures such asfluoroscopy or cardiology labs, requires a team (lab technician, nurse,and physician) of medical professionals, and requires a secondsubstantially difficult surgical procedure for filter removal.Additionally, the IVC filter placement procedure requires that thepatient's coagulation status be sufficient to withstand the surgicalprocedure. For example, if the patient has medical condition (liverfailure) or is on medications that prevents their blood from clotting(i.e., using anticoagulation therapy) there is a substantial risk ofexcessive bleeding during the procedure. Also, existing IVC filterplacement procedures are of questionable practicality for preventativeplacement because of the intrusive surgical procedures that must beperformed to place the filter. Correspondingly, the risks (particularlyfilter removal) must be balanced between the need for the filter and thepatient's ability to endure the surgical procedure.

Other complications may also arise from existing IVC filters. Forexample, despite FDA recommendations, the retrieval rate of IVC filtersis very low given the complexity of the procedure to remove the filters.When the filters remain in the body, there is the possibility of filterfracturing and migrating into other parts of the body. Further, thefilter may perforate the wall of the vein, and may even perforate intoadjoining tissues or organs.

As a result, there is a need in the art for a vascular filter that isinexpensive, facilitates placement by a physician at a convenientpatient location (bedside), allows non-intrusive removal that can beperformed at any location by either a physician or trained technicianwhile having minimal recovery time and eliminating the need to determinethe coagulation status of the patient. The method and vascular filterdescribed herein enables a physician to place and remove the filter withminimal physical intrusion and at the same time reducing risk ofprocedural complications for the patient.

SUMMARY

To overcome the drawbacks of the prior art and provide additionalbenefits and features, a vascular filter and method of filter placementis disclosed. In one embodiment, the vascular filter includes adispensing needle releasably attached to a syringe and a filter wiredispenser. Generally, the needle has two ends, a delivery end and acoupling end. The delivery end is placed within a vein and allows filterwire to be implanted into the vein. The coupling end allows the needleto be releasably connected to a filter wire dispenser or syringe.

The filter wire dispenser stores a length of filter wire which isconfigured to coil upon deployment from the delivery end of the needleinto a vein. The filter wire dispenser may store the filter wire as aspool or linearly, and includes a guide tube sized to insert into theneedle. The guide tube is used to guide the filter wire from thedispenser into the needle.

The filter wire may be configured to coil upon deployment in a number ofways. One way is to put residual stresses, surface tensions, or bothinto the filter wire such that, once deployed, the filter wire will coilinto a predetermined shape as defined by the stresses and surfacetensions in the filter wire. The filter wire may be configured to coilinto a vortex type, nested, or tangled web shape as desired. Inaddition, the filter wire of some embodiments may have a flexible tip tobetter prevent damage to the interior walls of a vein.

Once deployed a portion of the filter wire may be left protruding fromthe patient to allow the filter to be fixed in position. The protrudingportion of the filter wire may be secured to a fixation device attachedto the patient's skin. In one or more embodiments, the fixation devicemay have a portion configured to engage and secure the filter wire suchas a protrusion.

The vascular filter, in one embodiment, is implanted by accessing a veinwith a needle, attaching a filter wire dispenser storing a length offilter wire to the needle, and advancing the filter wire through theneedle such that the filter wire exits the delivery end of the needle.In one or more embodiments, the filter wire has two ends, a first endand a second end. In one embodiment the first end of the filter wireexits the dispenser first. As the filter wire exits the needle into thevein, it begins to coil, as described above, to form a vascular filter.

Once the vascular filter is fully deployed the needle may be removed. Inone or more embodiments, a portion of the filter wire is left protrudingout of the patient so that it may be secured to a fixation device whichgenerally covers the exist passage of the filter wire.

In some embodiments, proper access to a vein may be verified prior toimplanting the filter. One way to verify that the needle is accuratelylocated in a vein is to attach a syringe to the needle and draw bloodfrom the vein to confirm the needle is indeed properly within the vein.The needle is improperly placed if no blood can be drawn. Once verified,the syringe may be removed from the needle while leaving the needle inthe vein. A filter wire dispenser may then be attached and the filterwire implanted subsequently.

The vascular filter may be removed when desired or when no longerneeded. In one embodiment, the vascular filter is removed by removingthe filter wire from its associated fixation device and drawing thefilter wire out of the patient. As the filter wire is drawn out of thepatient, the filter wire unwinds itself so that it may be easilyremoved.

In one embodiment, a vascular filter system as described herein isprovided with medication infusion capability. In such an embodiment, thefilter wire is configured to coil within or around the filter wiredispenser and further configured for coiled deployment from the filterwire dispenser to a patient, the filter wire comprising an open firstend connected to a hub assembly. The filter wire includes an inner lumenwithin the filter wire in fluid communication with the open first end.The filter wire also includes a perforated section and a non-perforatedsection. Two or more infusion ports are in the perforated section suchthat the two or more infusion ports are in fluid communication with theinner lumen of the filter wire. A hub assembly is at the open first endsuch that the hub assembly is configured to surround at least a portionof the non-perforated section of the filter wire and selectively openand close the inner lumen to control the flow of medication into theperforated portion of the filter wire.

In one configuration, the infusion ports are holes in the perforatedsection of the filter wire which establish the inner lumen in fluidcommunication with the blood stream. The hub assembly may comprise aluer lock. In one embodiment, the hub assembly is configured to matewith a syringe to accept an administration of medication into the innerlumen of the filter wire.

Also disclosed is a vascular filter system that includes a length offilter wire having a first end and a second end. In this embodiment, thelength further includes a non-perforated section at the first end withan opening at the first end that is part of an inner passageway withinthe filter wire. A perforated section connects the non-perforatedsection and the second end such that the perforated section isconfigured to coil to form a filter upon deployment from the deliveryend of the dispensing needle. Also part of this embodiment are two ormore perforations in the perforated section that are in fluidcommunication with the inner lumen. A hub assembly is releasableconnected near the first end of the filter wire and is configured toselective open and close the inner lumen.

In one variation the vascular filter system further comprises anantithrombogenic on at least an outer surface of the perforated section.The portion of the filter wire that is within the hub assembly may beresilient.

In further embodiments, an infusion filter design is provided. Theinfusion filter design is a unique solution to the problem of DVT and PEmanagement by lessening time and financial cost while increasingprocedural efficiencies, decreasing the number of procedures andimproving patient care.

The new infusion filter design is unique in that it combines a means ofproviding blood filtration during the procedure with complete filterremoval of the filter on procedure completion. Some embodiments comprisethe ability for medication infusion and simultaneous blood filtration.In one embodiment, a wire comprises a proximal, non-infusible lengththat extends partially outside of the patient and within the vein. Thewire further comprises an infusible length distally from non-infusiblelength that is extends within the vein so as to be placed at the sectionof the vein requiring medication. The wire also comprises a distalfilter component at a distal end of the wire that is employed to filterthe blood in the event that during the period that clot is dissolved itmigrates toward the central circulation. The filter component can be ahelix shape, a vortex shape, a nested shape, and a tangled web shape.This infusion wire filter can be place using a catheter which theinfusion filter wire is advanced through, deployed and the catheterpulled back. Once the clot is removed the filter and wire can beremoved.

In another embodiment, the device incorporates two components: a wirewith a distal filter and an infusion catheter. The wire with the distalfilter is constructed with a non-infusible wire over the entire lengthwith the distal filter tip. The distal filter tip can be made of a helixshape, a vortex shape, a nested shape, and a tangled web shape and mayoppose or not oppose the inner vessel wall. The second component is aninfusion catheter which is composed of a single lumen catheter withnumerous perforations in the wall throughout its mid and distal length.The perforations are tiny holes which allow medication to infuse outwardfrom the inner lumen into the desired vessel. Assembled, the wire isadvanced through the infusion catheter and the filter component isdeployed beyond the distal catheter tip with the whole device within thedesired vessel. This configuration allows for infusion and bloodfiltration simultaneously which can then be removed upon completion ofthe procedure.

In these embodiments, the filter can either oppose or not oppose thevessel wall (float within the vessel).

Other systems, methods, features and advantages of the invention will beor will become apparent to one with skill in the art upon examination ofthe following figures and detailed description. It is intended that allsuch additional systems, methods, features and advantages be includedwithin this description, be within the scope of the invention, and beprotected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The components in the figures are not necessarily to scale, emphasisinstead being placed upon illustrating the principles of the invention.In the figures, like reference numerals designate corresponding partsthroughout the different views.

FIG. 1 illustrates a typical blood clot lodged within a femoral vein.

FIG. 2 illustrates an existing inferior vena cava filter and theproximate location of the filter in the upper abdomen.

FIG. 3 illustrates the inferior vena cava and the two femoral veins.

FIG. 4 illustrates a common femoral vein prior to access by a needle andsyringe assembly.

FIG. 5 illustrates actual needle and syringe assembly access into thecommon femoral vein.

FIG. 6 illustrates removal of the syringe.

FIG. 7 illustrates attachment of the filter dispenser to the needle.

FIGS. 8, 9, 10, and 11 illustrate deployment of the vascular filter.

FIGS. 12 and 13 illustrate removal of the filter dispenser and needle.

FIG. 14 illustrates retention of the filter wire to the patient's leg.

FIG. 15 illustrates a blood clot approaching the deployed vascularfilter.

FIG. 16 illustrates the blood clot of FIG. 15 trapped by the vascularfilter.

FIGS. 17, 18A, 18B, 18C, 18D, and 19 illustrate removal of the vascularfilter.

FIG. 20 illustrates an infusible filter and associated hub assembly.

FIG. 21A illustrates a more detailed view of the infusible filter andhub assembly including a close up of the filter wire with infusingmechanism.

FIG. 21B illustrates the assembly of FIG. 21A with the compressionelement compressed to close the inner lumen of the view of the filter.

FIG. 22 illustrates a close up view of the perforated section of filterwire with medication outflow holes.

FIGS. 23 and 24 illustrate the deployment of a guidewire into the commonfemoral vein.

FIG. 25 illustrates the deployment of a catheter along the guidewire.

FIG. 26 illustrates the removal of the guidewire.

FIG. 27 illustrates the deployment of the vascular filter.

FIG. 28 illustrates the retention of the filter wire in the patient'sleg.

FIG. 29 illustrates the removal of the vascular filter.

FIG. 30 illustrates the removal of the catheter.

FIG. 31 illustrates the deployment of a vascular filter according to afurther exemplary embodiment.

FIGS. 32 and 33 illustrate the removal of the vascular filter shown inFIG. 31.

FIG. 34 shows an infusion filter placed in the leg for treatment,according to one embodiment.

FIG. 35 shows an infusion filter design, according to one embodiment.

FIG. 36A shows an enlarged distal end of an infusion filter design, andFIG. 36B shows medicine infusion from the enlarged distal end shown inFIG. 36A, according to one embodiment.

FIG. 37 shows a device for placing an infusion filter, according to oneexemplary embodiment.

FIG. 38A shows a wire and filter for a system for performingthrombolysis, FIG. 38B shows a catheter for the system for performingthrombolysis, and FIG. 38C shows the combination of the wire andcatheter of FIGS. 38A and 38B, according to one embodiment.

FIG. 39 shows a method for performing thrombolysis, according to anexemplary embodiment.

DETAILED DESCRIPTION OF EMBODIMENTS

In the following description, numerous specific details are set forth inorder to provide a more thorough description of the present invention.It will be apparent, however, to one skilled in the art, that thepresent invention may be practiced without these specific details. Inother instances, well-known features have not been described in detailso as not to obscure the invention.

One of the primary concerns regarding deep vein thrombosis (DVT) is thatshould the thrombosis (blood clot) dislodge from the original location,the clot may travel to another region of the circulatory system andcause injury and or death to the subject. For example, if a DVTdislodges it may migrate through the heart and eventually re-lodge inthe lung of the subject, thus causing a pulmonary embolism (PE) whichprevents adequate circulation and respiration, and can cause suddendeath. By placing an intravenous filter in the common femoral vein, theblood clot is captured and prevented from migrating to vulnerableregions of the circulatory system. The filter may be placed in any veinor at any location such that the filter can capture a clot prior tocausing damage to the patient. The term vein and vessel are used anddefined interchangeably herein.

Referring now to the drawings, FIG. 1 illustrates a typical DVT wherethe common femoral vein 100 has a blood clot 102 lodged therein. As theblood clot 102 is formed there is reduced blood flow through the commonfemoral vein 100 because the blood clot begins to obstruct the fluidpathway. The reduced blood flow produces an environment that facilitatesclot formation. In particular, as the blood flow is reduced, bloodbegins to coagulate in the chambers of the vascular valves 104, and, asa result, the blood clot 102 increases in size.

FIG. 2 illustrates a known inferior vena cava vascular filter that issurgically implanted into the patient's upper abdomen. This inferiorvena cava filter (IVC filter) 200 is commonly deployed using a largebore catheter and access to a large bore vein such as the inferior venacava. The IVC filter 200 has a first end 202 and a second end 204 wherethe second end comprises a plurality of individual wire components 206.In the proximity diagram of FIG. 2, an IVC filter 200 is shown withinthe inferior vena cava at location 208 in the upper abdomen of apatient.

FIG. 3 illustrates the inferior vena cava 300 and two common femoralveins 302 branching off the inferior vena cava. In the known use ofintravenous filters such as the IVC filter discussed above, it is commonto place the IVC filter within the inferior vena cava 300 at location304 in the upper abdomen.

As stated above, placement of an IVC filter within the inferior venacava 300 is expensive, requires special surgical procedures, requiresimaging from a radiology or cardiology suite to ensure correct placementwith the inferior vena cava, and is a substantially difficult andcomplicated surgery. In addition, known IVC filters must be placed in alarge bore vein, and the placement surgery itself poses a significantrisk in patients with conditions that prevent proper blood clotting.

The vascular filter in the disclosed embodiments has several advantagesover known filters. In contrast to the above, the vascular filter of thedisclosed embodiments may be placed within one of the common femoralveins 302. In addition, the vascular filter may be placed at any otherlocation in the body which is suited to capture or retain blood clots toprevent the clots from migrating to more critical areas. The vascularfilter may be placed “blind” without imaging guidance from an expensiveradiology or cardiology suite. Furthermore, the vascular filter may beplaced in the common femoral vein 302 at hip level which is an arearoutinely used for catheter and other line access. Use of this commonaccess area is another advantage in that such use of a commonly accessedarea tends to reduce complexity and risk during placement as it is awell-known access area.

Though placement at hip level has advantages, placement at hip level maynot be ideal in all patients and thus the vascular filter may also beplaced in other areas. For example, in one embodiment, the filter may beplaced in the groin region 306 of the patient. It is contemplated thatthe vascular filter may be placed where it is best able to capture adislodged blood clot and that more than one filter may be placed toensure that any dislodged blood clots are captured. For example, in oneembodiment the vascular filter may be placed in both of the commonfemoral veins 302 should the patient's medical condition requirefiltration of both legs. In other embodiments, additional vascularfilters may be placed as well.

Placement of the vascular filter begins by accessing a common femoralvein 302. Though the following description describes an embodiment ofthe present invention where the vascular filter is placed within acommon femoral vein 302, the vascular filter may be similarly placed inother veins where dislodged blood clots may be captured as necessary.

FIGS. 4 and 5 illustrate a common femoral vein 302 accessed by adispensing needle 400 and syringe 402 assembly. In one or moreembodiments, the needle 400 has a first or delivery end through which avascular filter is implanted in a patient, and a second or coupling endat which a syringe or filter dispenser may be attached. Notably, thecoupling end in one or more embodiments may be configured to permitreleasable attachment of the needle 400 as described further below.

Generally, proper access to the common femoral vein 302 may be verifiedby syringe aspiration (drawing blood from the vein into the body of thesyringe) and is visually confirmed by blood return 500 into the syringe.In other embodiments, elements other than a syringe may be utilizedincluding, but not limited to a single hollow large bore needle of whichthe blood can be seen flowing out of without syringe aspiration.

As illustrated in FIG. 6, the syringe 402 may be disengaged or removedfrom the needle 400 without removing the needle from the common femoralvein 302. In one or more embodiments, proper access to the commonfemoral vein 302 may be confirmed prior to disengaging the syringe 402by inspecting the syringe for blood return. Such blood return confirmsthat the needle 400 is within a vein.

It is noted that disengagement or removal of the syringe 402 from theneedle 400 may occur in various ways and that the syringe is releasablyattached to the needle. For example, the syringe 402 may be fitted witha bayonet type of locking mechanism that retains the needle 400 withinthe end of the syringe. In addition, any other type of mechanism inaddition to or other than a bayonet type locking mechanism may beutilized including but not limited to a manufactured threaded couplingsystem with “male and female” thread components. The locking mechanismmay be any type of configuration that releasably retains the needle inthe syringe and because these mechanisms are well known in the art theywill not be described in detail so as not to obscure the presentinvention.

Attachment of the vascular filter dispenser 700 to the needle 400 isillustrated in FIG. 7. In one embodiment, the vascular filter dispenser700 is a spool device that is configured to house and dispense filterwire housed within the dispenser. The vascular filter dispenser 700 isfitted with a guide tube 702 that facilitates the deployment of thefilter wire from the dispenser through the needle 400 and into thecommon femoral vein 302. It is contemplated that the end of the guidetube 702 be sized for operative insertion into the inner diameter of theneedle 400. The guide tube 702 provides a smooth transition for thefilter wire during the deployment process as the wire leaves the filterdispenser 700 and enters the needle 400. In some embodiments, filtermeans other than a wire may be utilized such as but not limited tomonofilament strand or other materials with reformable properties. Thesestructures may be pre-formed or shaped and/or configured at the time ofuse.

Reference is now made to FIGS. 8 through 11 individually and incombination for illustrating the deployment of the vascular filter. Asshown in FIG. 8, a needle 400 and a vascular filter dispenser 700 arecoupled together, and the filter dispenser is actuated such that thefilter wire 800 is fed from the dispenser through the needle and intothe common femoral vein 302. In one embodiment, the filter dispenser 700is actuated by a rotational movement of the dispenser so that the filterwire 800 is un-coiled and fed down the guide tube 702 and into theneedle 400. It is contemplated that the filter dispenser 700 maycomprise a user-rotatable wheel or knob in one or more embodiments. Whenrotated, the knob un-coils the filter wire 800 and feeds the wire 800down the guide tube 702. The knob may un-coil the filter wire 800through physical contact with the filter wire. However, it iscontemplated that there may be an attached reel which is actuated byrotational movement of knob. Other embodiments of the filter dispenser700 are contemplated such as a linear dispenser by which the filter wireis translated down the length of the dispenser and into the needle.

As best illustrated in FIG. 9, as the filter wire 800 traverses down theneedle 400 it remains substantially straight. However, when the filterwire 800 exits the end 902 of the needle 400, the filter wire begins toform a coil 900 within the common femoral vein 302. The filter wirecoils due to residual stresses of the wire and the preformed shapememory imparted into the wire during the manufacturing process.

In one or more embodiments, the filter wire 800 has a first and a secondend and is preferably fabricated from a suitable material such astitanium, Nitinol, or monofilament strand, to name a few. The filterwire 800 may also be fabricated from a polymer as well. The wire may besimilar to known wires commonly used in the medical industry and, in oneor more embodiments, may range in diameter from 0.015-0.035 of an inch.Additionally, the filter wire 800 may be treated with a compound thatprevents clot formation on the wire such as a Heparin anticoagulationcoating. The wire may comprise a mesh form or may be constructed ofmetal, plastic or a combination thereof or any other material. Inaddition, the filter wire 800 may have a very flexible tip at its firstend to reduce the possibility of damaging the inside wall of a vein whenthe filter wire is implanted.

In one embodiment, an important characteristic of the filter wire 800 isthat the wire be preformed to have residual stresses and/or surfacetensions such that the wire will automatically coil once advanced beyondthe delivery needle end 902. For example, the filter wire may befabricated so that the surface tension along the length of the wirecauses the wire to naturally coil unless otherwise constrained. In thisway, the filter wire 800 may be housed or stored in one dispenserconfiguration and upon proper deployment; the filter wire would coilinto a predetermined shape. In another embodiment, the filter wire maybe preformed to take any various shapes that will achieve the goals setforth herein. For example, the filter wire may be preformed to have avortex shape (coils of increasing/decreasing diameter) once deployed.Other embodiments may provide filter wire that is preformed to have anesting or tangled web shape.

As illustrated in FIGS. 10 and 11, as the filter wire 800 is advancedinto the common femoral vein 302, the coil 900 becomes larger and longersuch that a substantial coil of wire is formed within the vein. As aresult, the coil 900 becomes a partial flow restriction within thecommon femoral vein 302 capable of capturing and retaining a blood clottherein.

In FIG. 12, the filter wire 800 has been deployed and the filterdispenser 700 and delivery needle 400 are retracted from the subject'scommon femoral vein 302. As the dispenser 700 and needle 400 areremoved, a portion 1200 of the filter wire 800 may be left protrudingfrom the subject's skin surface 1202 so that it may be secured to afixation device 1300 (FIG. 13) to prevent the filter wire 800 frommoving within the vein. As illustrated in FIGS. 13 and 14, a portion1200 of the filter wire 800 is intentionally left protruding from thesubject's skin surface 1202 so that it may be looped and subsequentlyattached to a fixation device 1300. The fixation device 1300 is thensecured using a medical dressing to the subject's skin 1202 and maycover the filter wire's exit. It is contemplated that types of fixationdevices 1300 other than those illustrated in the figures may be used,and that in other embodiments the protruding portion 1200 of the filterwire 800 may be attached in other ways such as by tying or adhering thefilter wire to the fixation device.

FIGS. 15 and 16 illustrate a blood clot 1500 approaching and beingcaptured by the deployed vascular filter. As the blood clot 1500migrates down the vein, it will encounter and preferably become trappedby the coil 900 of the vascular filter. As illustrated in FIG. 16, theblood clot 1500 will become lodged or entangled with the vascularfilter's coils, and, in this way, the clot is prevented from enteringother regions of the subject's circulatory system.

In the event that a blood clot 1500 is captured by the vascular filter,the clot may be removed in one of several ways. First, the entangledblood clot 1500 may be verified using ultrasound or x-ray techniques. Ifthere is a blood clot 1500, then the blood clot may be dissolved usinganticoagulation therapy or any other means. If the blood clot 1500 doesnot dissolve in a timely manner, the attending physician may decide toperform additional procedures such as thrombectomy or thrombolysis toresolve the blood clot. In some cases, permanent placement of a standardIVC filter may be required where the blood clot does not dissolve.

FIGS. 17 through 19 illustrate removal of the vascular filter. In FIG.17, the fixation device 1300 and associated dressing are removed fromthe patient's skin surface 1202. Next, the protruding portion 1200 ofthe filter wire 800 is drawn away from the patient. As the filter wire800 is drawn out of the patient, the filter coil 900 unwinds and/orunravels as illustrated in FIGS. 18A through 18D. A hydrophilic coatingor hydrophilic filter wires 800 may be used, in one or more embodiments,to facilitate removal of the filter coil 900. Once the filter wire 800is completely extracted from the patient as shown in FIG. 19, thevascular filter has been successfully removed and may be discarded.

The vascular filter disclosed herein has several advantages over knownIVC filters. The new vascular filter is inexpensive and easilydeployed/removed with minimal intrusion to the patient. In contrast,existing vascular filters require a complex and potentially riskydeployment procedure which is very expensive, requires a team of medicalprofessionals and the use of an operating room or cardiology suite.Additionally, existing vascular filters require an even more complicatedand risky procedure for removal.

The new vascular filter is placed without the need for complexfluoroscopic guidance (i.e., the new filter may be placed blindly). Forexample, unlike existing filters that are placed within the inferiorvena cava which requires x-ray fluoroscopic guidance for deployment, thenew vascular filter may be placed without using any x-ray or imagingequipment.

The new vascular filter is minimally invasive and can be deployed at thepatient's bedside or in an emergency room setting. Correspondingly,removal of the new vascular filter may be performed at a convenientlocation such as bedside.

The new vascular filter reduces the risk of complications because thefilter is placed in a more conducive location within the patient's body.As disclosed herein, the new vascular filter may be placed in the pelvicor groin region of the patient unlike existing IVC filters which aregenerally placed in the upper abdomen or thoracic region. As a result,the new vascular filer is placed within one or both of the moreaccessible common femoral veins and is minimally intrusive for thepatient. Another desirable aspect of the new vascular filter is asubstantial reduction in recovery time for either deployment or removalof the new filter. In contrast, the existing filters require asubstantial recovery time for both deployment and removal.

As an improvement to the filter and method of use described above, alsodisclosed is the filter configured as a route for infusion of fluids,gels, or medications through the filter and into the blood stream. Theinfused material may medicate the entire body or vascular system, orjust the area of the filter. As such treatment can be directed to a verydirect and focused area of the body or arterial system. As discussedabove, the filter may be used to retain clots and as such, while theclot is retained within the filter, medication may be applied or infusedthrough the filter as disclosed below to target the retained clot. Thisprovides the benefit of concentrating the medication to the clot whichis particularly useful for application of clot dissolving medicationsuch as, but not limited to, Tissue Pasminogen Activator(TPA—Alteplase). In addition, it is also contemplated that medicationmay be infused through the filter as described below to prevent clottingof the blood around or onto the filter, or any other type of build-up ofmaterial or growth on the filter. This extends the effective life of thefilter within the body and increases the ease of removal.

FIG. 20 illustrates an infusible filter and associated hub assembly. Asdiscussed above, the filter 1600 is located within the vascular system,such as vein 1604 located below the surface of the skin 1608. A hubattachment 1620 connects to the externally located end 1624 of thefilter 1600. The base function of the filter 1600 operates as describedabove and in connection with FIGS. 1-19. In this embodiment the filter1600 including the externally located end 1624 includes an innerpassageway that is configured to conduct medication or other materialsuch as a liquid or gel. The passageway may comprise a lumen.

The filter wire maybe categorized into a perforated section 1630 whichis contained within in the vascular system. The filter wire alsoincludes an un-perforated section 1634 that connects the perforatedsection 1630 at a distal end and to the attachment hub at the proximalend. The perforated section has one or more openings (shown in FIG. 21)through which the medication or other material may exit the filter. Thenumber and shape of the openings may be varied to meet the requirementsof the filter, medication, and particular medical application.

The filter sections 1630, 1634 includes a passage between an open end atthe hub attachment 1620 and the perforations (not shown in FIG. 20) forthe movement of the medication or other material into the filter,through the filter, and out of the perforations. The hub attachment1620, the structure of which is discussed below in connection with FIG.21, serves several purposes and functions. The hub attachments providesan access port to the internal passage within the filter sections 1630,1634 to thereby provide an input port for the medication or othermaterial. The hub attachment 1620 also provides a clamping orcompression element to open and close the opening into the internalpassage of the filter. This controls the flow of medication or othermaterial into and output of the internal passage. The hub attachment1620 also provides an attachment point and structure to attach asyringe, drip line, medication storage/dispensing device infusion pump,or any other element configured to deliver medication or other materialto the filter.

FIG. 21A illustrates a more detailed view of the infusible filter andhub assembly including a close up of the filter wire with infusingmechanism. This is but one possible configuration of the filter and hubassembly. It is contemplated that in other embodiments otherconfigurations may be realized without departing from the claims thatfollow. For example, different medical applications may require that thedisclosed and claimed device interface with other medical devices and assuch modifications may be made to the device shown without departingfrom the scope of the invention and claims.

As shown generally, the filter includes hub attachment 1620 and thefilter wire 1600. A non-perforated section of the filter wire connectsthe perforated filter section to the hub assemble. The filter may bemade from any type material that is configured to perform as describedherein.

A fluid chamber 1640 configured to connect to the hub assembly, which inthis embodiment is a luer lock 1644. The fluid chamber 1640 containsmedication or other material which is provided to the filter 1600 andultimately to the patient. The fluid chamber may be part of a syringe,drip-line, infusion pump or medication administration device or anyother element configured to store and connect to a hub assembly. Thefluid chamber 1640 may permanently connect to the filter or may beselectively connectable and removable to apply medication or othermaterial to the filter.

Configured to mate with or connect to the fluid chamber 1640 is a luerlock 1644 having a first end 1648 with an opening configured to matewith the external shape of the fluid chamber 1640, in this embodiment atapered end. The hub attachment 1620 assembly is an addition to theprior art as it allows wire placement, such as for example, through aneedle with the eventual needle removal. Once the entry needle isremoved the hub assembly 1620 can be applied to the portion of thefilter that is external to the body for infusion.

The luer lock 1644 is generally known in the art and not describe indetail herein. As shown the luer lock 1644 has an internal passageway orlumen from the first end 1648 to a second end 1652. In the second end1652 is an opening 1656 configured in size and shape to accept aproximal end 1660 of the non-perforated section 1644 filter wire. Theopening extends toward the proximal end of the luer lock 1644 to aestablish fluid (or there material state) passageway with the fluidchamber 1640. Through this fluid passageway medication or other materialmay be provided to the filter wire 1600. The medication or othermaterial may be pressurized in the fluid chamber 1640 to establish flowinto the lower pressure filter wire. The pressure may be established bya syringe or gravity, or any other force to move the medication or othermaterial from the chamber 1640 to the filter wire.

The luer lock 1644 also includes an outer ring 1664 with internalthreaded which rotationally interact with an externally threaded innerframe 1668 of the luer lock. Through rotational movement of the outerring 1664 relative to the inner frame 1668 the outer ring moves in thelinear direction between the proximal end 1648 and the distal end 1652.

The movement of the outer ring 1664 relative to the inner frame 1668crushes an compression element 1670 that when crushed closes the passagebetween the chamber 1640 and the internal passageway in the filter 1600.The compression element 1670 may comprise any material capable ofperforming as described herein. The compression element 1670 is a knownstructure in the luer lock 1646 and it may also be known to pinch orotherwise close the flow of medication or other material into the filter1600.

In one configuration the non-perforated section 1634 of the filter incontact with the compression element 1670 may comprise a differentmaterial or configuration than the portion of the filter not in contactwith the compression element. For example, the non-perforated section1634 of the filter in contact with the compression element 1670 may beflexible and resilient to return to shape after opening, while theperforated section 1630 may comprise a more stiff material capable offunctioning as described above as a filter in a vascular environment.

FIG. 21B illustrates the assembly of FIG. 21A with the compressionelement compressed to close the inner lumen of the view of the filter.As shown the outer ring 1664 is twisted relative to the inner frame 1668to compress (shown at element 1671) the compression element 1670, whichin turn compresses the inner passageway or lumen to stop the flow ofmedication or other material.

Also shown in FIG. 21A is a close up view 1631 of the perforated section1630 of the filter. Each of the dots in the coiled filter wire compriseopening or holes through which the medication or other material may passinto the blood steam

FIG. 22 illustrates a more detailed version of the filter. As shown theperforated section 1630 of the filter includes an outer wall 1680 whichforms an inner passage 1678 or lumen through which medication or othermaterial may flow or be placed. Perforating through the wall 1680 areopenings 1684 which provide passages for the medication or othermaterial to exit the inner passageway 1678 or lumen and enter thebloodstream. The openings 1684, which may referred to herein as infusionpores or diffusion pores, may be of any various size and shape and suchsize and shape may depend on the medication or other material, dosingrequirements, patient condition or numerous other factors.

This current improvement allows the place filter to be a route ofinfusion for fluids and/or medication. The enhanced filter with infusioncapabilities can therefore aid in patient care as an extra source ofvenous access, provides an additional means to protect the filter itselffrom developing blood clots and potentially will provide a means ofbreaking up or dissolving the trapped clot via infusion of clotdissolving medications including but not limited to Tissue PlasminogeActivater (TPA) and any other medication now existing or develop in thefuture.

In summary, once the filter has been placed medication can be infuseddirectly into the blood stream via the inner lumen and multiple infusionpores (openings) located on the intravenous portion of the filter wire.In order to channel fluid through the inner lumen of the filter coil acustom coupling apparatus is provided to attach to a syringe or otherdevice configured to present the medication into the inner passage ofthe filter wire. The coupler, such as hub assembly, allows for thefilter wire with the open inner lumen to be put into fluid communicationwith a standard IV drip system or other medication administrationmechanism via a luer lock connection (hub assembly). Within the coupleris a compression seal (4). When the two coupler bodies are threadedtogether the compression seal is deformed thus creating a fluid tightseal around the filter wire. Once a seal is made the coupler can beconnected to an IV line allowing fluid to pass through the filter wireand infuse into the patient's blood stream.

It is further contemplated that various coatings can be added to thesurface of the filter to enhance its biocompatibility or prevent/inhibitgrowth or development of unwanted surface tissue by the body on thefilter. An example is an antithrombogenic antiplatelet coating ormaterial to prevent development thrombi in vitro. This may furtherprevent or reduce development of clots or scar tissue development on thevascular filter.

The above-described vascular filters may also be inserted and removed byother methods. In FIG. 23, the needle 400 is inserted into a patient'svein, such as the common femoral vein. A guidewire 2310 is insertedthrough the needle 400 into the vein. The guidewire 2310 may have acurved tip 2312, such as a u-shaped or a j-shaped tip to facilitatenavigation of the guidewire 2310 through the vein and to preventcatching of the guidewire on the vein. The guidewire 2310 may be storedon a reel or other storage device, or inserted as a length of wire. Whenthe guidewire 2310 is deployed in the vein, the needle 400 may beremoved as shown in FIG. 24.

In addition and in reference to FIG. 25, the guidewire may also be usedto establish a sheath or catheter 2510 in a patient. As shown, a sheathor catheter 2510 is utilized to deploy the vascular filter, as will bedescribed in more detail below. The catheter 2510 has a proximal end2512 and a distal end 2514. A proximal end of the guidewire 2310 outsideof the patient is inserted into the distal end 2514 of the catheter2510, and the catheter is guided over the guidewire 2310 to be insertedinto the patient. In this manner, the catheter 2510 is inserted into thepatient's vein at a predetermined location along the guidewire 2310. Theguidewire 2310 acts as a guide for the catheter. Once the catheter 2510is properly placed within the vein, the guidewire 2310 is removed bypulling the guidewire 2310 out from the proximal end 2512 of thecatheter 2510 as shown in FIG. 26. It is also contemplated that theguidewire 2510 may be left in place to facilitate filter removal, or forother medical procedures.

With the catheter 2510 in place, the filter may be inserted in a mannersimilar as explained with reference to FIGS. 7-11 above. That is, asshown in FIG. 27, a filter dispenser 700 may connect with and insert adistal end of the filter 900 into the proximal end 2512 of the catheter2510. When the filter 900 exits the distal end 2514 of the catheter2510, residual stresses in the filter 900 cause the filter wire to coiland form the filter within the patient's vein. In other embodimentsdeployment in a manner other than coiling may occur.

In FIG. 28, the proximal end of the catheter 2510 (or sheath) isconfigured with a valve or seal on or in the exposed end that allows thefilter wire (or guide wire) to be placed and advanced/withdrawn withoutallowing air into the catheter or blood from escaping from the catheter.In this configuration, a “plug” may be mainly used to prevent the wirefrom advancing further into thee vein. This plug may be referred to as a“wire fixation clamp or plug”. In another embodiment, the catheter 2510is plugged by a fixation plug 2810 or any other device or element suchas tape, adhesive, ring/loop or the like. The fixation plug 2810 holdsthe filter 900 in position with respect to the inserted catheter 2510and may prevent infection while the filter 900 is in place. The catheter2510 may be plugged with the fixation plug 2810 or other element toprevent blood flow from the catheter.

Removal of the filter is shown in FIGS. 29 and 30. Here, the filter 900is removed by pulling the filter 900 through the catheter 2510 and outof the proximal end 2512 of the catheter. Once the filter 900 isremoved, the catheter 2510 is then removed. In this embodiment, thefilter 900 may be safely and easily removed by way of the catheter 2510inserted in the patient. This is due to the pulling force on the filter900 to be substantially parallel to the vein with the filter is removedthrough the catheter 2510. The catheter 2510 also protects the skin andvein by providing a protective wall between the filter 900 and the skinand vein. It is contemplated that this system may be used with any typefilter such as a filter having an interior passage and outlets formedication disbursement. The filter 900 may also be of any shape andhaving one or more barbs or rough surfaces to catch the edge of thevein. The filter 900 material may also be smooth to prevent adhesion tothe veins.

Further modifications may be made within the scope of the invention. Forexample, as shown in FIG. 31, the filter may be configured to have an“umbrella” end 3100. That is, the end of the filter may be split intoseveral different threads. The filter may deploy from the needle orcatheter. The residual stresses within the threads of the umbrella endexpand the threads into the umbrella shape 3100 once deployed from theneedle 400 (a catheter such as catheter 2510 may also be used). Thethreads of the umbrella filter 3100 are formed to be flexible such thatwhen the filter is removed, as shown in FIG. 32, the threads flex backand allow easy removal from the vein. It also contemplated that forremoval, a flexible sheath may be inserted through a placement needleuntil the sheath contacts the umbrella portion of the filter causing thethreads of the umbrella to collapse backwards and into the sheath forremoval from the vessel. Although discussed for use in vein, it iscontemplated that the filters may be used in any type or location ofblood vessel.

FIG. 34 shows an infusion filter placed in the leg for treatment,according to one embodiment. In FIG. 34, a leg 3400 of a patient isshown that has a clot 3404 within a vein 3404. Such clots 3404 mayextend a substantial length through the vein 3402 as shown. One methodof treating clots 3404 is via thrombolysis, as previously explained. Inthis embodiment, a new infusion filter 3410 is provided to perform thethrombolysis to remove the clot, as will be explained in more detailbelow.

FIG. 35 shows an infusion filter design, according to one embodiment. Itshould be noted that the infusion filter design is not shown to scale,but rather the features are shown to aid in understanding. The relativelengths and sizes of the features in the filter design may vary. In FIG.35, an infusion filter 3410 comprises a wire with a first proximallength 3512. The first proximal length 3512 is comprised of a hollowinner lumen for fluid transfer with solid circumferential outer wallwhich is non-permeable. Distally from the first proximal length 3512 isan infusion portion 3514 of the wire that is composed of a permeableouter wall. In one embodiment, the infusion portion 3514 may be formedto have a plurality of holes manufactured therein. Other methods toproduce the infusion portion 3514 of the wire 3410 may also be used.

FIG. 36A shows an enlarged distal end of an infusion filter design, andFIG. 36B shows medicine infusion from the enlarged distal end shown inFIG. 36A, according to one embodiment. As shown in FIG. 36A, theinfusion portion 3514 may comprise several manufactured holes 3620. Theholes 3620 may be manufactured via punching, penetrating, or molding theinfusion portion 3514, among other methods. Alternately, the infusionportion 3514 may be designed with as woven techniques or materials thatare fabricated with micro pores, as well as other means. In FIG. 36B,medication or other fluids 3622 is shown leaving the infusion portion3514 via the holes 3620. In this manner, medication or fluid may betransported to a specific location in a vein or other blood vessel.

Returning to FIG. 35, the infusion filter 3410 further comprises afilter portion 3516 of the wire at a distal end of the infusion filter3410. The filter portion 3410 can be configured into a helix shape, avortex shape, a nested shape, a tangled web shape, or any other suitablefilter shape and can be either porous or non-porous depending on thematerials used and their configuration. Similar to the filters describedabove, the filter portion 3516 is configured with residual stresses orsurface tensions such that the filter 3516 takes shape once deployedfrom a sheath or catheter within a blood vessel.

On the proximal end of the filter 3410, a luer lock type adaptor 3518 isemployed that can be attached to a syringe or medical tubing formedication infusion. The luer lock adapter may be either prefixed to thewire or may be an attachment that is attached to the infusion wire. Forexample, the infusion wire may be advanced into the vessel to thedesired location and then the luer lock attached to add an infusingcapability.

As shown in FIG. 34, the filter 3410 is inserted into the vein 3402 froman access point around the knee area 3406 of the leg 3400. The filter3410 is then inserted through the clot 3404 so that the filter portion3516 can be deployed downstream in the vein 3402 from the clot 3404.FIG. 37 shows a device for placing an infusion filter, according to oneexemplary embodiment. An infusion device specific for wires such as aTuohy-Borst Adapter may be used. In FIG. 37, a configuration fordeployment is illustrated where the filter portion 3516 of the infusionfilter wire 3410 is loaded in a straight configuration within an outercover 3724. The filter portion 3516 is deployed when advanced through acatheter or sheath by inserting the outer cover 3724 into the opening ofa catheter or sheath then advancing the filter wire 3410 through thevein until it is at the desired location. The filter portion 3516 isthen advanced out of the outer cover 3724 until the filter portion 3516assumes it neutral coiled or previously preconfigured design. The outercover 3724 is then removed by way of a peel-away design commonly used inthe field. In other embodiments, the filter wire 3410 can be configuredwith or without the luer lock 3518 and can be connected directly forinfusion using a Tuohy Borst infusion connecter. In this configurationthe deployment cover, catheter or sheath can be removed without need forpeal-away design.

FIG. 38A shows a wire and filter for a system for performingthrombolysis, FIG. 38B shows a catheter for the system for performingthrombolysis, and FIG. 38C shows the combination of the wire andcatheter of FIGS. 38A and 38B, according to one embodiment. It should benoted that the wire and catheter described below are not shown to scale,but rather the features are shown to aid in understanding. In FIG. 38A,a filter wire 3810 is provided with a filter portion 3816 at a distalend of a wire extension portion 3812. The wire extension portion extendsthrough the access point of the patient and into the blood vessel todeploy the filter portion 3816 at the desired location. The filter wire3810 comprises a stopper 3826 proximal to the filter portion 3816. Thewire 3810 is configured to be deployed within the vein as described inother embodiments above.

As shown in FIG. 38B, an infusion catheter 3830 is also provided. Thecatheter 3830 comprises a luer lock type device 3836 on a proximal endto which tubing or other equipment may be attached to dispense medicineor fluid into the catheter. The catheter 3830 further comprises anon-infusible length 3832 extending distally from the luer lock device3836. The non-infusible length 3832 is configured to extend through theincision in a patient and extend into the vein of the patient andincludes an interior lumen to transport a fluid. An infusible length3834 extends distally from the non-infusible length 3832. The infusiblelength 3834 may comprise several holes or may be constructed to beotherwise permeable such that a fluid or medication flowing from thenon-infusible length 3832 is conveyed from the interior lumen of theinfusible length 3835 to the outside of the infusible length 3835.

As shown in FIG. 38C, when the catheter 3830 and the filter wire 3810are deployed, the catheter 3830 extends over and covers the filter wire3810 up to the stopper 3826. The stopper 3826 is configured to block theflow of fluid from within the lumen of the catheter 3830 such that thefluid is forced to flow through the holes (or other permeableconstruction) of the infusion length 3834 of the catheter 3830 and intothe blood vessel. The stopper 3862 may be omitted in some embodimentswhere the distal tip of the catheter 3830 is configured with a smallvalve (such as for example a distal end flow valve) which creates a sealaround the wire 3810. This allows infusion with a bare wire extendingbeyond the tip while still creating a seal in which pressure can developin the catheter to infusion of medication or other substance into thebloodstream can occur.

FIG. 39 shows a method for performing venous thrombolysis, according toan exemplary embodiment. In step 3902, a medical professional deploys aguide wire into and through a blood clot of a patient. For example, asshown in FIG. 34, a patient may have a blood clot 3404 in an upper leg3400 that extends through a vein 3402 in the upper leg 3400. The guidewire is inserted into the vein upstream from the clot and is directedcompletely through the clot until a distal end of the guidewire reachesa downstream side of the clot. Once the guidewire is positioned, acatheter is inserted over the guidewire, as described in step 3904. Withcatheter in position, the guide wire may then be removed.

In step 3906, an infusion filter, such as the one described above, isdeployed through the catheter. The infusion filter is positioned so thatthe filter portion of the infusion filter is deployed downstream in theblood vessel from the clot. Once the infusion filter is in position, thecatheter may be removed as described in step 3908. The infusion filteris deployed such that the infusion portion aligns with the blood clot inthe patient's blood vessel. When the infusion filter is in place,medication or other fluid may be pumped into the infusion filter andforced through the infusion portion of the filter in step 3910.

For the exemplary thrombolysis method described here, a thrombolyticagent such as those known in the art is fed through the infusion filterinto the infusion portion to treat the blood clot by dissolving theblood clot. The infusion filter allows the thrombolytic agent to bedirected along the length of the blood clot to help dissolve the bloodclot. Furthermore, with the filter portion being disposed downstreamfrom the blood clot, any pieces of the dissolving clot that might breakaway are filtered and prevented from traveling to other areas of thebody where they might cause significant injury or death, such as via apulmonary embolism. Pieces of the clot caught in the filter may then begradually dissolved from the medication dispensed through the infusionportion. In some embodiments, the filter portion may also be permeableas described above such that the thrombolytic agent is dispense directlyto any clot pieces caught in the filter.

The fluid is dispensed through the infusion filter for a period of timeas prescribed by the medical professional. For example, the treatmentmay last two days. In step 3912, the infusion filter may be removed oncethe treatment is complete. The infusion filter is removed similar to theremoval of the filters described above. The filter portion of theinfusion filter is designed with pitch angles and materials such thatthe filter can be pulled back out through the incision.

The infusion filter and method for performing thrombolysis describedabove have a number of advantages. First, as compared to prior systemswhere a filter is deployed by a separate procedure, usually by accessingthe jugular vein and guiding the filter through the body to be deployedon the downstream side of the clot in the interior vena cava, thepresent embodiments allow the filter to be easily placed from an accesspoint upstream from the clot.

Further, the infusion filter dispenses the medication, such as thethrombolytic agent, directly at the site of and throughout the length ofthe blood clot. This allows a total amount of medication delivered todissolve the clot to be decreased. When the amount of medication isdecreased, the safety of the procedure is increased because the risk forthe thrombolytic agent to cause damage elsewhere (such creating internalbleeding) is decreased. The safety is also increased due to effectivefiltering of the vein downstream from the clot. When the clot dissolvesfrom the thrombolytic agent, any large pieces of the clot are filteredand dissolved rather than entering the bloodstream and possiblyresulting in a pulmonary embolism or the like. Finally, when thetreatment is complete, the filter may be immediately removed without aseparate complicated procedure to retrieve the filter.

Other variations of the above described method may also be used. Forexample, instead of the infusion filter, a filter and infusion cathetermay also be used, such as the ones described with reference to FIGS.38A-38C. The filter portion of the infusion filter might also bedeployed via a sheath and a filter cover, as described with reference toFIG. 37. Other modification or combinations with any other embodimentsdescribed herein may also be utilized.

While various embodiments of the invention have been described, it willbe apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible that are within the scopeof this invention. In addition, the various features, elements, andembodiments described herein may be claimed or combined in anyconfiguration or arrangement.

What is claimed is:
 1. An infusion filter comprising: a non-infusiblelength wire extending from a proximal end of the infusion filter, thenon-infusible length comprising a lumen extending therethrough; aninfusible length wire extending distally from the non-infusible lengthwire, the infusible length wire comprising a lumen extendingtherethrough and a permeable wall; and a filter portion extending fromthe infusible length wire, the filter portion comprising residualstresses, surface tensions, or both that cause the filter portion toform a predetermined shape when deployed in a blood vessel.
 2. Theinfusion filter of claim 1, wherein the permeable wall comprises aplurality of holes.
 3. The infusion filter of claim 1, wherein thepredetermined shape comprises one of a helix shape, a vortex shape, anested shape, and a tangled web shape.
 4. The infusion filter of claim1, further comprising an outer cover that is disposed over the filterportion and is removable from the filter portion when the filter portionis deployed.
 5. The infusion filter of claim 1, further comprising aluer lock on a proximal end thereof to convey a fluid to the lumen ofthe non-infusible length wire.
 6. The infusion filter of claim 1,wherein the filter portion comprises a lumen and a permeable wall.
 7. Aninfusion filter system comprising: a filter wire comprising: a wireextension portion configured to extend through an access point of apatient and into a blood vessel; a filter portion disposed at a distalend of the wire access portion, the filter portion comprising residualstresses, surface tensions, or both that cause the filter portion toform a predetermined shape when deployed in the blood vessel; and astopper disposed proximally from the filter portion; and a cathetercomprising: a non-infusible length extending from a proximal end of thecatheter, the non-infusible length comprising a lumen extendingtherethrough; an infusible length extending distally from thenon-infusible length wire, the infusible length comprising a lumenextending therethrough and a permeable wall; the catheter covering atleast a portion of the wire extension portion and a distal end of thecatheter abutting against the stopper to prevent flow from the distalend of the catheter when deployed.
 8. The infusion filter system ofclaim 7, wherein the permeable wall comprises a plurality of holes. 9.The infusion filter system of claim 7, wherein the predetermined shapecomprises one of a helix shape, a vortex shape, a nested shape, and atangled web shape.
 10. The infusion filter system of claim 7, furthercomprising a luer lock on a proximal end thereof to convey a fluid tothe lumen of the non-infusible length wire.
 11. A method for performingvenous thrombolysis comprising: deploying a guidewire within a bloodvessel from an upstream side of a blood clot so that a distal end of theguidewire reaches a downstream side of the blood clot; inserting acatheter over the guidewire; removing the guidewire while the catheteris in place; deploying an infusion filter through the catheter, theinfusion filter comprising: a non-infusible length wire extending from aproximal end of the infusion filter, the non-infusible length comprisinga lumen extending therethrough; an infusible length wire extendingdistally from the non-infusible length wire, the infusible length wirecomprising a lumen extending therethrough and a permeable wall; and afilter portion extending from the infusible length wire, the filterportion comprising residual stresses, surface tensions, or both thatcause the filter portion to form a predetermined shape when deployed ina blood vessel; positioning the infusion filter such that the infusiblelength wire is adjacent to the blood clot and the filter portion isdisposed downstream from the blood clot; removing the catheter withinfusion filter in place; dispensing medication into the blood vesselthrough the permeable wall for a predetermined treatment period; andremoving the infusion filter from the patient.
 12. The method of claim11, wherein the permeable wall comprises a plurality of holes.
 13. Themethod of claim 11, wherein the predetermined shape comprises one of ahelix shape, a vortex shape, a nested shape, and a tangled web shape.14. The method of claim 11, wherein the infusion filter furthercomprises an outer cover that is disposed over the filter portion and isremovable from the filter portion when the filter portion is deployed.15. The method of claim 11, wherein the infusion filter furthercomprises a luer lock on a proximal end thereof to convey the medicationto the lumen of the non-infusible length wire.
 16. The method of claim11, wherein the filter portion comprises a lumen and a permeable wall.